Health IT NEWS.Direct!

 January - March 2012

INTERVIEW
Mobile Healthcare and the Law

Q. What are the laws that cover mobile health activities? How stringent are
these laws in the current day practice?

A. There are no specific laws which govern the process of providing medical
guidance through mHealth. What would be applicable are those laws which
govern a normal patient/doctor relationship. The question of liability of the
application provider would be governed by contract law.

In fact, the patients rights are basically indirect rights, which arise or flow from
the obligations of a physician or healthcare provider under the Indian Medical
Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002.

Dr Milind Antani The basic principle is that medical doctors and associated medical professionals
Head - Pharma & Life Science are responsible and liable for wrongs and failures in the performance of their
Nishith Desai Associates medical duties towards patients.

In India, generally, Section 304-A of the Indian Penal Code (IPC), 1860, is the relevant
provision under which a complaint against a medical practitioner for alleged
criminal medical negligence is registered. Section 304-A provides that whoever
commits culpable homicide not amounting to murder shall be punished for life
or imprisoned for a term up to 10 years and fined as well. Section 337 of the IPC
deals with hurt caused by an act endangering the life or personal safety of others.

However, the simple lack of care attracts only civil liability. Therefore, only civil
negligence may not be enough to hold a medical professional criminally liable.

Q. What are the possible legal liabilities that we could expect with the delivery
of health through mobile phones? What are the legal aspects that physicians
practicing mHealth should be aware of?

A. Negligence and possibility of malpractice is what the providers of mHealth

services should be aware of. The courts in India have generally followed the
decisions and practices of the English law. The cases of negligence in India are
directly related to existing facilities, infrastructure, and level of acumen of medical
professionals. In many cases, doctors have been held liable for negligent acts,
such as removal of a wrong eye or a kidney, or surgery on wrong limb, based on
pecuniary interest or where minimum facilities were available. In this regard,
an important example is of eye camps or health camps where operations are
performed without proper facilities.

The Supreme Court of India in its landmark judgment in the Indian Medical

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January - March 2012
Association vs V.P. Shanta1, laid down the law relating
to professional negligence under Consumer Protection
Act 1986, and enunciated certain principles that medical
practitioners, government hospitals, and private hospitals
and nursing homes are also covered under the consumer
law in the following categories:2
1. Where services are rendered free of charge to
everybody availing of the said service
2. Where charges are required to be paid by persons
availing of services, but certain categories of persons
who cannot afford to pay are rendered service free
of charge
The services provided in the first category by doctors and
hospitals would not be covered by the services under
section 2(1) (0) of the Consumer Protection Act, 1986,3
but those rendered by the second and third categories of
doctors and hospitals would be covered within the ambit
of the service defined in the above provision of the Act.
Q. What could be the consequences of malpractice by a
physician outside the geographical jurisdiction treating a
patient remotely?
A. In the past, courts would use the standard of the
particular locale where the tortuous act took place,
invoking the so-called locality rule. This was based on the
belief that different standards of care were applicable in
different areas of the country, e.g., urban or rural. However,
this rule has been largely abandoned in favor of a uniform
standard, because medical training and board certifications
all adhere to a national standard. Telemedicine has further
propagated this uniformity. With the erosion of the locality
rule, courts now readily allow out-of-state experts to
testify on behalf of the opposing parties. This has been
especially helpful for plaintiffs who are far less likely to be
able to secure willing experts from the local community.
Geographical considerations are not entirely irrelevant.
Where the local medical facilities lack state-of-the-art
equipment or specialists, courts will look at the existing
circumstances. However, there is always the duty to refer
and transfer to an available specialist, and the failure to do
AIR 1996 S.C. 550
1
Id. at 563-6
2
Section 2(1) (0) Provides: Services means service of any description
3
is made available to potential users and includes the provision of
facilities in connection with banking, financing, insurance, transport,
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INTERVIEW
so may form the basis of liability.
In a key decision on this matter in the case of Dr Laxman
Balkrishna Joshi vs Dr Trimbak Bapu Godbole, the Supreme
Court held that if a doctor has adopted a practice that
is considered proper by a reasonable body of medical
professionals who are skilled in that particular field, he
or she will not be held negligent only because something
went wrong.
Q. How will a technology as dynamic as telecommunication
be able to abide by privacy and security issues?
A. To answer this question, it would entirely depend upon
what the doctor has communicated to the patient. From
a legal point of view, any recommendations or advice by a
doctor shall not constitute a prescription; however, courts
have allowed doctors to recommend in acute emergency
cases.
If the patient already has an established relationship with
the physician, there is a risk, just as there is if the physician
takes a phone call over a standard landline. When the
physician is asked a question of a professional nature, hes
being called upon to make a professional judgment and
recommend a course of action to deal with the patients
problem. In the diagnostic effort or the recommended
therapy, one could make a mistake. When there is the
possibility of a mistake, thats where malpractice risk arises.
On the other hand, if there was no prior relationship
between the two, there is greater risk.
If X is Ys doctor and Y has been Xs patient and Y has been
communicating his condition, and if they decide to engage
in communication via smartphone, the communication isnt
different, just the mechanism differs. The symptoms are
still spoken about and advice is being given on that basis.
If with a patient, the doctor doesnt have a relationship
and the doctor doesnt have a great deal of history or
information to help, it becomes a harder job to do.
The treating doctor is bound by the code of ethics regulations
processing, supply electrical or other energy, boarding or lodging or
both, (housing construction), entertainment, amusement, or purveying
of news or other information, but does not include the rendering of
any service free of charge or under a contract of personal service.
23 Copyright 2012
Health IT NEWS.Direct!
prescribed by the Medical Council of India regarding the
confidentiality of information pertaining to patients. At
the same time, doctors have to abide by the Information
Technology (Reasonable security practices and procedures,
and sensitive personal data or information) Rules, 2011.
Q. Do you think that there should be an additional
certification for healthcare professionals to practice
mHealth? Will there come a time when mobile devices
would have to be certified by regulatory bodies like FDA
and CCHIT?
A. Though additional certification may not be necessary
for doctors practicing on mobile health platform, new
regulatory changes are likely to come.
Q. Do you think that the lack of a regulatory framework
is a deterrent to technological advancements in tele or
mobile healthcare delivery?
A. Lack of a clear, regulated, and mandated structure would
allow for a leeway to utilize the loopholes of the law to the
advantage of the mHealth service providers. While this can
promote an atmosphere of proactive competition, it should
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January - March 2012
not reach a stage where any monopolistic tendencies come
into existence or worst of all, if the patient is not getting
any healthcare promised by the companies. So, while at the
international scenario, it can be said that there is adequate
regulatory framework, the same cannot be said for India.
Proper regulatory framework should definitely help the
telemedicine industry.
Q. What in your opinion is the way forward to meeting
these regulatory challenges, globally?
A. Various mobile technologies are creating an explosion
of mHealth solutions and devices. While foreign regulatory
bodies have already taken steps to provide a structure, the
same cannot be said of the Indian equivalents. Thus, when
a system is established abroad and is effective, the Indian
bodies may adopt the same, which would be beneficial
to the mHealth providers and the patients/users as well.
To meet the possible challenges, one way would be to
set up a means of communication between regulatory
bodies of different countries and try to implement best
practices from all over. As mentioned earlier, to have a
comprehensive law covering telemedicine in India is the
need of the hour.
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